LymphomaPhase 2NCT02106988
Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma
A Phase 2 study testing Radiation Therapy, Dexamethasone and Etoposide phosphate in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and chemotherapy combination will also be studied. This is an investigational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Radiation Therapy, Dexamethasone and Etoposide phosphate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2015to 31 Jan 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed stage I and II nasal NK cell lymphoma.
- Adequate blood cell counts (i.e. ANC > 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin.
- Patients must have adequate liver function as indicated by: *Bilirubin </= 1.5 times the upper limit of normal (ULN), * Alanine transaminase (ALT) </= 2 times the (ULN) or aspartate transaminase (AST) </= 2 times the ULN, *These values must be obtained within two weeks before protocol entry.
- Patients are required to have a serum creatinine </= 2.0 mg/dL. This value must be obtained within two weeks before protocol entry.
- Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >/= 50%.
- Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
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- Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
- Female patients of childbearing potential must have a negative serum pregnancy test (BhCG) within 2 weeks of protocol entry.
- Patients must have the ability to give informed consent.
Who cannot join
- Patients with active Hepatitis B and/or Hepatitis C infection.
- Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
- Patients known to be HIV positive.
- Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: a) Congestive heart failure class III/IV CHF per new york heart association (NYHA) criteria. b) Cardiomyopathy, c) Uncontrolled cardiac arrhythmia, d) Unstable angina pectoris, e) Recent MI (within 6 months).
- Patients who are pregnant or breast-feeding.
- Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
- Prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma
The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and chemotherapy combination will also be studied.
This is an investigational study. Radiation and chemotherapy are FDA approved and commercially available for patients with Stage 1 and/or 2 NK cell lymphoma. The combination of these therapies given at the same time is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Read the detailed description
Radiation Therapy:
You will receive radiation therapy 5 days a week for 28 to 30 treatments (up to 6 weeks). You will receive a separate consent form that will describe this treatment and its risks in more detail.
Study Visits During Radiation Therapy:
Every week during radiation therapy:
- You will have a physical exam.
- Blood (about 1 teaspoon) will be drawn for routine tests.
Chemotherapy Administration:
You will start Cycle 1 of chemotherapy during your first week of radiation. Each cycle will be 21-days long (or longer if it takes longer for your blood cell counts to recover). You will receive up to 3 cycles of chemotherapy.
On Days 1-3 of each cycle:
- You will receive dexamethasone by vein over about 15 minutes.
- You will receive etoposide by vein over 2 hours.
- You will receive ifosfamide by vein over 3 hours.
- Mesna is given to protect the bladder from side effects. You will receive mesna by vein as a non-stop infusion over 24 hours on Days 1-3 of each cycle.
- On Day 1 only, you will receive carboplatin by vein over 30 minutes.
Study Visits During Chemotherapy:
On or before Day 1, on Day 15 of Cycle 2, and on Day 15 of Cycle 3, blood (about 2 teaspoons) will be drawn for routine tests. You may also have an EKG, if the doctor thinks it is needed.
On or before Day 1 of Cycle 3:
- You will have an EKG, if the doctor thinks it is needed.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Length of Study:
You may receive radiation and up to 3 cycles of chemotherapy. You will no longer be able to receive chemotherapy if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over after the end-of-study and follow-up visits.
Follow-Up Visits:
You will also have routine follow-up visits every 3 months for the 1st year, every 4 month during the 2nd year, and every 6 months during the 3rd-5th years. After that, you will have follow up visits 1 time every year. At these visits, the following tests and procedures will be performed:
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Any skin lesions that you may have that are related to the tumor will be measured and photographed.
If your doctor thinks it is needed, your MRI and PET/CT scans will be performed more or less often.
If you leave the study early:
- You will have CT, MRI, and PET/CT scans to check the status of the disease.
- Any skin lesions that you may have that are related to the tumor will be measured and photographed.
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Conditions
- Lymphoma
- Being tested
- Radiation Therapy, Dexamethasone, Etoposide phosphate, Ifosfamide, Mesna
- Keywords
- Lymphoma, NK cell lymphoma-nasal type, Radiation therapy, XRT, Dexamethasone, Decadron, Etoposide, VePesid, Ifosfamide, Ifex, Mesna, Mesnex, Carboplatin, Paraplatin
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Also called XRT
Radiation therapy delivered for a total dose of 50.4 to 54 Gy 5 days a week for 28 to 30 treatments.
DexamethasoneDrug
Also called Decadron
40 mg by vein Days 1-3 in a 21 day cycle.
Etoposide phosphateDrug
Also called VePesid
67 mg/m2 by vein on Days 1-3 of a 21 day cycle.
IfosfamideDrug
Also called Ifex
1 g/m2 by vein on Days 1-3 of a 21 day cycle.
MesnaDrug
Also called Mesnex
0.4 g/m2 by vein on Days 1-3 with Ifosfamide, 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump.
CarboplatinDrug
Also called Paraplatin
200 mg/m2 by vein on Day 1 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Radiation Therapy | Experimental | Radiation therapy delivered for a total dose of 50.4 to 54 Gy over 28 to 30 treatments. Within seven days of starting radiotherapy, the first cycle of chemotherapy started and repeated every 3 weeks for a total of 3 cycles.
DeVIC on day 1 of every cycle. Dexamethasone 40 mg by vein Days 1-3, Etoposide 67 mg/m2 by vein on Days 1-3, Ifosfamide 1 g/m2 by vein on Days 1-3, Mesna 0.4 g/m2 by vein on Days 1-3 with Ifosfamide, Mesna 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump, Carboplatin 200 mg/m2 by vein on Day 1. Cycles repeated every 21 days. Receives: Radiation: Radiation Therapy; Drug: Dexamethasone; Drug: Etoposide phosphate; Drug: Ifosfamide; Drug: Mesna; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression defined as progressive disease or death due to disease. The evaluation of PFS will include all participants who receive radiation, regardless of whether they receive chemotherapy. Progression free survival measured from protocol entry.
Measured: From registration to disease progression or death due to disease, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start16 Jan 2015
- Primary completion31 Jan 2034 (estimated)
- Study completion31 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bouthaina Dabaja, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106988
- Sponsor's protocol ID
- 2013-0367
- Other IDs
- NCI-2014-01356
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2014
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02106988
- Acronym / sponsor ID
- 2013-0367
- Conditions
- Lymphoma
- Keywords
- Lymphoma, NK cell lymphoma-nasal type, Radiation therapy, XRT, Dexamethasone, Decadron, Etoposide, VePesid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Jan 2015 (actual)
- Primary completion
- 31 Jan 2034 (estimated)
- Study completion
- 31 Jan 2034 (estimated)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and chemotherapy combination will also be studied.
This is an investigational study. Radiation and chemotherapy are FDA approved and commercially available for patients with Stage 1 and/or 2 NK cell lymphoma. The combination of these therapies given at the same time is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Detailed description
Radiation Therapy:
You will receive radiation therapy 5 days a week for 28 to 30 treatments (up to 6 weeks). You will receive a separate consent form that will describe this treatment and its risks in more detail.
Study Visits During Radiation Therapy:
Every week during radiation therapy:
- You will have a physical exam.
- Blood (about 1 teaspoon) will be drawn for routine tests.
Chemotherapy Administration:
You will start Cycle 1 of chemotherapy during your first week of radiation. Each cycle will be 21-days long (or longer if it takes longer for your blood cell counts to recover). You will receive up to 3 cycles of chemotherapy.
On Days 1-3 of each cycle:
- You will receive dexamethasone by vein over about 15 minutes.
- You will receive etoposide by vein over 2 hours.
- You will receive ifosfamide by vein over 3 hours.
- Mesna is given to protect the bladder from side effects. You will receive mesna by vein as a non-stop infusion over 24 hours on Days 1-3 of each cycle.
- On Day 1 only, you will receive carboplatin by vein over 30 minutes.
Study Visits During Chemotherapy:
On or before Day 1, on Day 15 of Cycle 2, and on Day 15 of Cycle 3, blood (about 2 teaspoons) will be drawn for routine tests. You may also have an EKG, if the doctor thinks it is needed.
On or before Day 1 of Cycle 3:
- You will have an EKG, if the doctor thinks it is needed.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Length of Study:
You may receive radiation and up to 3 cycles of chemotherapy. You will no longer be able to receive chemotherapy if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over after the end-of-study and follow-up visits.
Follow-Up Visits:
You will also have routine follow-up visits every 3 months for the 1st year, every 4 month during the 2nd year, and every 6 months during the 3rd-5th years. After that, you will have follow up visits 1 time every year. At these visits, the following tests and procedures will be performed:
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Any skin lesions that you may have that are related to the tumor will be measured and photographed.
If your doctor thinks it is needed, your MRI and PET/CT scans will be performed more or less often.
If you leave the study early:
- You will have CT, MRI, and PET/CT scans to check the status of the disease.
- Any skin lesions that you may have that are related to the tumor will be measured and photographed.
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Radiation Therapy | Experimental | Radiation: Radiation Therapy, Drug: Dexamethasone, Drug: Etoposide phosphate, Drug: Ifosfamide, Drug: Mesna, Drug: CarboplatinRadiation therapy delivered for a total dose of 50.4 to 54 Gy over 28 to 30 treatments. Within seven days of starting radiotherapy, the first cycle of chemotherapy started and repeated every 3 weeks for a total of 3 cycles. DeVIC on day 1 of every cycle. Dexamethasone 40 mg by vein Days 1-3, Etoposide 67 mg/m2 by vein on Days 1-3, Ifosfamide 1 g/m2 by vein on Days 1-3, Mesna 0.4 g/m2 by vein on Days 1-3 with Ifosfamide, Mesna 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump, Carboplatin 200 mg/m2 by vein on Day 1. Cycles repeated every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with newly diagnosed stage I and II nasal NK cell lymphoma.
- Adequate blood cell counts (i.e. ANC > 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin.
- Patients must have adequate liver function as indicated by: *Bilirubin </= 1.5 times the upper limit of normal (ULN), * Alanine transaminase (ALT) </= 2 times the (ULN) or aspartate transaminase (AST) </= 2 times the ULN, *These values must be obtained within two weeks before protocol entry.
- Patients are required to have a serum creatinine </= 2.0 mg/dL. This value must be obtained within two weeks before protocol entry.
- Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >/= 50%.
Key exclusion criteria (7 listed)
- Patients with active Hepatitis B and/or Hepatitis C infection.
- Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
- Patients known to be HIV positive.
- Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: a) Congestive heart failure class III/IV CHF per new york heart association (NYHA) criteria. b) Cardiomyopathy, c) Uncontrolled cardiac arrhythmia, d) Unstable angina pectoris, e) Recent MI (within 6 months).
- Patients who are pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyAlso: XRTRadiation therapy delivered for a total dose of 50.4 to 54 Gy 5 days a week for 28 to 30 treatments. | Radiation | Chemotherapy + Radiation Therapy |
| DexamethasoneAlso: Decadron40 mg by vein Days 1-3 in a 21 day cycle. | Drug | Chemotherapy + Radiation Therapy |
| Etoposide phosphateAlso: VePesid67 mg/m2 by vein on Days 1-3 of a 21 day cycle. | Drug | Chemotherapy + Radiation Therapy |
| IfosfamideAlso: Ifex1 g/m2 by vein on Days 1-3 of a 21 day cycle. | Drug | Chemotherapy + Radiation Therapy |
| MesnaAlso: Mesnex0.4 g/m2 by vein on Days 1-3 with Ifosfamide, 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump. | Drug | Chemotherapy + Radiation Therapy |
| CarboplatinAlso: Paraplatin200 mg/m2 by vein on Day 1 of a 21 day cycle. | Drug | Chemotherapy + Radiation Therapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From registration to disease progression or death due to disease, up to 5 years
Progression defined as progressive disease or death due to disease. The evaluation of PFS will include all participants who receive radiation, regardless of whether they receive chemotherapy. Progression free survival measured from protocol entry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bouthaina Dabaja, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation Therapy, Dexamethasone and Etoposide phosphate in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From registration to disease progression or death due to disease, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.